<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
53045-126-60
</NDCCode>
<PackageDescription>
60 mL in 1 BOTTLE, SPRAY (53045-126-60)
</PackageDescription>
<NDC11Code>
53045-0126-60
</NDC11Code>
<ProductNDC>
53045-126
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Iolite-s
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzocaine
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
DENTAL
</RouteName>
<StartMarketingDate>
20210104
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Dharma Research, Inc.
</LabelerName>
<SubstanceName>
BENZOCAINE
</SubstanceName>
<StrengthNumber>
12
</StrengthNumber>
<StrengthUnit>
g/100mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-06-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210104
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>